← FDA DRUG APPROVALS

FDA ANDA · ANDA040578

BENZPHETAMINE HYDROCHLORIDE

Sponsor: SCINOPHARM TAIWAN

APPLICATION
ANDA040578
TYPE
ANDA
ORIGINAL APPROVAL
2006-04-17
LATEST ACTION
2010-05-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BENZPHETAMINE HYDROCHLORIDEDiscontinued
BENZPHETAMINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2010-05-10Labeling · Supplement 11AP
2009-08-31Labeling · Supplement 10AP
2009-05-21Labeling · Supplement 9AP
2006-04-17OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →